Advanced Lung CancerEarly Phase 1NCT06928922
mRNA Vaccine for Advanced Lung Cancer and Pulmonary Metastases of Solid Tumors
A Early Phase 1 study testing BMD006 monotherapy, BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) and BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) in people with Advanced Lung Cancer and Lung Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors. This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Advanced Lung Cancer, Lung Metastasis
- What is being tested?
- BMD006 monotherapy, BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) and BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to 24 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF).
- Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible.
- Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options.
- Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years.
- Presence of at least one measurable lesion as defined by RECIST V1.1
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1
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- Organ function must be adequate at screening (no need for blood transfusion, hematopoietic growth factors, human albumin, or medications for correction within 14 days prior to first treatment), specifically defined as: a) Hematology: Absolute neutrophil count ≥1.5×10^9/L; platelet count ≥90×10^9/L; hemoglobin ≥90 g/L (9 g/dL). b) Liver Function: Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); for patients with liver metastasis or a history/suspected history of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated bilirubin, with no evidence of hemolysis or liver pathology), TBIL ≤3×ULN; for patients without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); for patients with liver metastasis, ALT or AST ≤5×ULN. c) Renal Function: Creatinine (Cr) ≤1.5×ULN or creatinine clearance (CLcr) ≥60 mL/min (calculated using the Cockcroft-Gault formula, see Attachment 3); urine dipstick test result showing urinary protein <2+; for patients with baseline urine dipstick showing protein ≥2+, a 24-hour urine collection should be conducted, and the protein content in the 24-hour urine should be <1 g. d) Cardiac Function: Echocardiography showing left ventricular ejection fraction (LVEF) >50%. e) Pulmonary Function: Shortness of breath ≤Grade 1 as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), and outdoor ambient air oxygen saturation (SpO₂) ≥92%.
- Expected life expectancy ≥12 weeks.
- Female patients of childbearing potential and male patients (and their female partners) must use highly effective contraception from the screening period until at least 6 months after the last dose of the study drug. Patients must not plan to conceive, donate sperm, or donate eggs during this period
Who cannot join
- Patients with lung cancer who have concurrent other types of malignant tumors or are diagnosed with multiple primary malignancies, except for the following: completely resected basal cell carcinoma and squamous cell carcinoma of the skin, completely resected any type of carcinoma in situ.
- Symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or those whose symptoms have been stable for ≥2 weeks after treatment of brain metastasis, they may participate in this study if they meet all the following criteria: measurable lesions in the lungs; cessation of steroid treatment 14 days prior to the first trial product dose.
- Patients with chronic obstructive pulmonary disease (COPD), asthma, or allergies to pollen or dust.
- Patients suspected of having active or latent tuberculosis infection, based on interferon-γ release assay results, clinical symptoms, and/or chest imaging findings (patients with evidence of adequately treated prior active tuberculosis infection may be enrolled after assessment by the investigator; for latent tuberculosis, patients must have completed at least 4 weeks of anti-tuberculosis treatment, with no liver function impairment [ALT ≤3×ULN, AST ≤3×ULN], and after the investigator assesses that the risk is manageable, they may be considered for continued screening or enrollment).
- History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, non-infectious pneumonia requiring immunosuppressive treatment such as corticosteroids.
- Patients with active autoimmune diseases requiring therapeutic intervention.
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- History of serious bleeding disorders; or those with coagulation dysfunction (as indicated by laboratory tests or medical history) who are deemed by the investigator to be unsuitable for the trial treatment.
- History or current diagnosis of cardiovascular disease, including any of the following: a) Recent myocardial infarction or coronary artery bypass grafting (CABG) within the past 6 months; b) Uncontrolled congestive heart failure; c) Unstable angina (within the past 6 months); d) Clinically significant (symptomatic) arrhythmias (e.g., sustained ventricular tachycardia, clinically significant second- or third-degree atrioventricular block without a pacemaker).
- Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion/pericardial effusion; patients with effusions that do not require drainage or those whose effusions have not increased significantly after stopping drainage for 3 days may be included).
- Severe infection requiring intravenous antibiotic treatment or hospitalization at screening, or any uncontrolled active infection within 4 weeks prior to the first dose of the trial product.
- History of severe allergic reactions, or known allergy to any active or inactive component of BMD006 or PD-1 inhibitors.
- Any other metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, or gastrointestinal disease that, in the investigator's opinion, may present unacceptable risks to the patient during treatment.
- Presence of unresolved toxicity from prior anti-tumor treatments before the first dose of the study product, which has not recovered to Grade 0 or 1 (excluding alopecia) (severity assessed according to NCI CTCAE v5.0).
- Positive test results for hepatitis B at screening [defined as: ① Hepatitis B surface antigen (HBsAg) positive; ② HBsAg negative but hepatitis B core antibody (HbcAb) positive (further testing through hepatitis B virus deoxyribonucleic acid [HBV DNA] is required, and patients with HBV DNA levels exceeding the normal limit for the test method must be excluded)], positive hepatitis C antibody (HCV Ab) [further testing through hepatitis C virus ribonucleic acid (HCV RNA) is required, and patients with HCV RNA levels exceeding the normal limit for the test method must be excluded], or positive human immunodeficiency virus antibody (HIV Ab).
- Underwent major surgery within 4 weeks prior to the first dose of the trial product (cranial, thoracic, or abdominal surgery) or has an unresolved wound, ulcer, or fracture. Note: Thoracoscopic surgery and mediastinoscopy will not be considered major surgery. Patients who are ≥2 weeks post-surgery or who are deemed eligible by the investigator may be included in the study.
- Previously received similar products or treatments.
- Received other anti-tumor treatments (radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the trial product.
- Received systemic immunosuppressive agents (e.g., systemic corticosteroids) within 3 months prior to the first dose of the trial product.
- Received or planned to receive live or attenuated live vaccines within 3 months prior to the first dose of the trial product or during the study.
- Pregnant or breastfeeding women.
- Participated in any clinical drug trial (defined as being randomized and receiving trial product treatment) within 3 months or 5 half-lives (whichever is longer) prior to screening.
- Any other condition deemed by the investigator to make the patient unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Ning Li, Doctor, +86156 0139 5554, lining@cicams.ac.cn
About this study
Official title: The Phase I Clinical Study of mRNA Vaccine BMD006 in Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors
BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors.
This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or are ineligible for standard therapeutic options. This trial also further explores the clinical efficacy of BMD006 in combination with Immuno-Oncology (IO) therapy.
Read the detailed description
This is a single-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or have no available standard treatment options. In addition, this study aims to explore the clinical efficacy of BMC001 in combination with Immuno-Oncology (IO) therapy.
The trial comprises three study arms: BMD006 monotherapy dose escalation, BMD006 plus IO therapy dose escalation, and BMD006 plus IO therapy dose expansion.
- Conditions
- Advanced Lung Cancer, Lung Metastasis
- Being tested
- BMD006 monotherapy, BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation), BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)
- Keywords
- mRNA vaccine, advanced lung cancer, solid tumors with lung metastasis, mRNA vaccine combined with Immuno-Oncology (IO) therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMD006 monotherapyBiological
Following the initial BMD006 administration, subjects will undergo DLT observation for single treatment. If investigators confirm acceptable safety and tolerability, subjects will enter DLT observation for multiple treatment. After satisfactory safety assessment, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria.
BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation)Biological
Once the dose escalation of BMD006 monotherapy is completed and the MTD (Maximum Tolerated Dose) is determined (i.e., the RP2D for this study), dose escalation exploration of BMD006 in combination with Immuno-Oncology (IO) therapy will be initiated. Subjects will undergo DLT observation. If investigators confirm acceptable safety and tolerability, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria.
BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)Biological
Group 1 receives combination therapy with BMD006 and Immuno-Oncology (IO) therapy.
Group 2 receives BMD006 monotherapy initially. After the initial treatment phase, investigators will assess potential clinical benefits, and IO therapy will be added for combined treatment thereafter.
| Study group | Role | What they receive |
|---|---|---|
| BMD006 monotherapy | Experimental | In this trial, patients receive BMD006 monotherapy. The investigators will assess the safety and tolerability of the treatment. Eligible patients will continue to receive treatment at the assigned dose until 52 weeks after the first administration or until meeting the study termination criteria. Receives: Biological: BMD006 monotherapy |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) | Experimental | For the cohort of BMD006 in combination with Immuno-Oncology, investigators will assess the safety and tolerability of the treatment. Eligible patients will continue to receive treatment at the assigned dose until 52 weeks after the first administration or until meeting the study termination criteria. Receives: Biological: BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) | Experimental | Subjects will be assigned to either the BMD006 plus IO therapy group (Group 1) or the BMD006 monotherapy followed by IO combination therapy group (Group 2).
Group 1 receives combination therapy with BMD006 and IO therapy. Group 2 receives BMD006 monotherapy initially; after the initial treatment phase, investigators will assess potential clinical benefits, and then IO therapy will be added for combined treatment. Receives: Biological: BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dose-limiting toxicities（DLTs）
Number of participants experiencing dose-limiting toxicities（DLTs）
Measured: about 2 years
Determine the maximum tolerated dose（MTD） of BMD006
Determine the maximum tolerated dose（MTD） of BMD006
Measured: about 2 years
Determine the recommended phase II dose (RP2D) for the clinical study.
Determine the recommended phase II dose (RP2D) for the clinical study.
Measured: about 2 years
number of participants experiencing adverse events（AEs）
number of participants experiencing adverse events（AEs）
Measured: about 2 years
Secondary outcomes (8)
overall response rate（ORR）
The percentage of patients who achieved the best overall response of complete response (CR) or partial response (PR) as evaluated by investigators based on RECIST V1.1
Measured: Up to 12 months
Disease Control Rate(DCR)
The percentage of patients who achieved CR, PR, or SD)as assessed by investigators based on RECIST V1.1.
Measured: Up to 12 months
Duration of Response(DOR)
The investigators evaluated the time from objective remission to the first recorded disease progression or death (whichever occurred first) based on RECIST V1.1;
Measured: Up to 12 months
Progression-Free Survival (PFS)
The time between the first treatment date and the date of the first recorded disease progression or death (whichever occurs first) evaluated by the investigator according to RECIST V1.1;
Measured: Up to 12 months
Overall Survival(OS)
The time between the first treatment date and the date of the patient's death due to any reason.
Measured: Up to 12 months
The 6-month and 12-month overall survival (OS) rates.
The 6-month and 12-month overall survival (OS) rates.
Measured: Up to 6 or 12 months
The proportion and activation status of antigen-specific T cells in peripheral blood and tumor tissue (if available)
The proportion and activation status of antigen-specific T cells in peripheral blood and tumor tissue (if available)
Measured: about 2 years
The titers of antigen-specific antibodies IgG and IgA in serum
The titers of antigen-specific antibodies IgG and IgA in serum
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start24 Feb 2025
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928922
- Sponsor's protocol ID
- BMD006-001
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase I Clinical Study of mRNA Vaccine BMD006 in Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06928922
- Acronym / sponsor ID
- BMD006-001
- Conditions
- Advanced Lung Cancer, Lung Metastasis
- Keywords
- mRNA vaccine, advanced lung cancer, solid tumors with lung metastasis, mRNA vaccine combined with Immuno-Oncology (IO) therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BMD006 is an off-the-shelf antitumor mRNA vaccine targeting lung cancer and lung metastatic solid tumors.
This is a single-center, open-label, dose-escalation clinical trial. The study aims to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or are ineligible for standard therapeutic options. This trial also further explores the clinical efficacy of BMD006 in combination with Immuno-Oncology (IO) therapy.
Detailed description
This is a single-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have progressed on or have no available standard treatment options. In addition, this study aims to explore the clinical efficacy of BMC001 in combination with Immuno-Oncology (IO) therapy.
The trial comprises three study arms: BMD006 monotherapy dose escalation, BMD006 plus IO therapy dose escalation, and BMD006 plus IO therapy dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMD006 monotherapy | Experimental | Biological: BMD006 monotherapyIn this trial, patients receive BMD006 monotherapy. The investigators will assess the safety and tolerability of the treatment. Eligible patients will continue to receive treatment at the assigned dose until 52 weeks after the first administration or until meeting the study termination criteria. |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) | Experimental | Biological: BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation)For the cohort of BMD006 in combination with Immuno-Oncology, investigators will assess the safety and tolerability of the treatment. Eligible patients will continue to receive treatment at the assigned dose until 52 weeks after the first administration or until meeting the study termination criteria. |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) | Experimental | Biological: BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)Subjects will be assigned to either the BMD006 plus IO therapy group (Group 1) or the BMD006 monotherapy followed by IO combination therapy group (Group 2). Group 1 receives combination therapy with BMD006 and IO therapy. Group 2 receives BMD006 monotherapy initially; after the initial treatment phase, investigators will assess potential clinical benefits, and then IO therapy will be added for combined treatment. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Able to understand and comply with the requirements of the study protocol, voluntarily participate in the trial, and sign a written informed consent form (ICF).
- Must be at least 18 (inclusive) at the time of signing the ICF, and both male and female participants are eligible.
- Histologically or cytologically confirmed as advanced lung cancer (driver gene negative) or advanced solid tumors with lung metastasis, and having failed prior standard treatments or having no standard treatment options.
- Agree to provide fresh tumor tissue samples or archived tumor tissue samples within the past three years.
- Presence of at least one measurable lesion as defined by RECIST V1.1
Key exclusion criteria (22 listed)
- Patients with lung cancer who have concurrent other types of malignant tumors or are diagnosed with multiple primary malignancies, except for the following: completely resected basal cell carcinoma and squamous cell carcinoma of the skin, completely resected any type of carcinoma in situ.
- Symptomatic central nervous system metastasis; for patients with asymptomatic brain metastasis or those whose symptoms have been stable for ≥2 weeks after treatment of brain metastasis, they may participate in this study if they meet all the following criteria: measurable lesions in the lungs; cessation of steroid treatment 14 days prior to the first trial product dose.
- Patients with chronic obstructive pulmonary disease (COPD), asthma, or allergies to pollen or dust.
- Patients suspected of having active or latent tuberculosis infection, based on interferon-γ release assay results, clinical symptoms, and/or chest imaging findings (patients with evidence of adequately treated prior active tuberculosis infection may be enrolled after assessment by the investigator; for latent tuberculosis, patients must have completed at least 4 weeks of anti-tuberculosis treatment, with no liver function impairment [ALT ≤3×ULN, AST ≤3×ULN], and after the investigator assesses that the risk is manageable, they may be considered for continued screening or enrollment).
- History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, non-infectious pneumonia requiring immunosuppressive treatment such as corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMD006 monotherapyFollowing the initial BMD006 administration, subjects will undergo DLT observation for single treatment. If investigators confirm acceptable safety and tolerability, subjects will enter DLT observation for multiple treatment. After satisfactory safety assessment, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria. | Biological | BMD006 monotherapy |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation)Once the dose escalation of BMD006 monotherapy is completed and the MTD (Maximum Tolerated Dose) is determined (i.e., the RP2D for this study), dose escalation exploration of BMD006 in combination with Immuno-Oncology (IO) therapy will be initiated. Subjects will undergo DLT observation. If investigators confirm acceptable safety and tolerability, subjects will continue treatment at the assigned dose until 52 weeks after the first administration or until meeting treatment discontinuation criteria. | Biological | BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) |
| BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion)Group 1 receives combination therapy with BMD006 and Immuno-Oncology (IO) therapy. Group 2 receives BMD006 monotherapy initially. After the initial treatment phase, investigators will assess potential clinical benefits, and IO therapy will be added for combined treatment thereafter. | Biological | BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) |
Primary outcome
Number of participants experiencing dose-limiting toxicities（DLTs）
Time frame: about 2 years
Number of participants experiencing dose-limiting toxicities（DLTs）
Determine the maximum tolerated dose（MTD） of BMD006
Time frame: about 2 years
Determine the maximum tolerated dose（MTD） of BMD006
Determine the recommended phase II dose (RP2D) for the clinical study.
Time frame: about 2 years
Determine the recommended phase II dose (RP2D) for the clinical study.
number of participants experiencing adverse events（AEs）
Time frame: about 2 years
number of participants experiencing adverse events（AEs）
8 secondary outcomes
overall response rate（ORR）
Time frame: Up to 12 months
Disease Control Rate(DCR)
Time frame: Up to 12 months
Duration of Response(DOR)
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival(OS)
Time frame: Up to 12 months
The 6-month and 12-month overall survival (OS) rates.
Time frame: Up to 6 or 12 months
The proportion and activation status of antigen-specific T cells in peripheral blood and tumor tissue (if available)
Time frame: about 2 years
The titers of antigen-specific antibodies IgG and IgA in serum
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BMD006 monotherapy, BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Escalation) and BMD006 in combination with Immuno-Oncology (IO) therapy (Dose Expansion) in people with Advanced Lung Cancer and Lung Metastasis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuhang Wang, Doctor (+86135 8180 9307, snowflake201@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing dose-limiting toxicities（DLTs） (time frame: about 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.